The purpose of this study is to determine if magnesium pantoprazole 20 mg twice a day (b.i.d.), maintains gastric pH above 4 during a longer percentage of time than magnesium pantoprazole 40 mg once a day (qd). This is a comparison between split dose concept and standard dose of proton pump inhibitors.

Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry. [ Time Frame: Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period. ] [ Designated as safety issue: No ]

Electrode will be placed in the gastric lumen, 10 cm below the lower esophageal sphincter. The percentage of time with pH >4.0 between both treatments will be compared.

Treatment sequences will be administrated as follows: 6 days with the first medication, followed by a washout period of 8 days (no medication) and a further period of 6 days with the second medication.

Treatment efficacy will be established by the percentage of time with intragastric pH >4, measured by 24-hour pH-Metry on day 6 of each medication (on-treatment measurement). Basal pH will be measured as reference.

The blinding distribution of treatments will be maintained for the patients, the doctor and the statistician who will analyze the data.

Women under breastfeeding period, pregnant or under pregnancy suspicion.

Subjects with abnormal manometry (any motor esophageal disorder).

Peptic ulcer history and/or ulcer complication.

Volunteers under PPI treatment, H. pylori eradication treatment, H2 receptor antagonists, prokinetics or similar medication (current, during the last 30 days or during the trial).

History of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAID) use, during the last 30 days.

Abnormal laboratory parameters or vital signs, considered clinically relevant by the researcher.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499693